(220 days)
No.
The document explicitly states "Not Found" for "Mentions AI, DNN, or ML" and describes a device for visualization and endoscopic treatment with no mention of AI functionalities.
Yes.
Explanation: The device is intended for "endoscopic treatment," which implies a therapeutic function beyond just diagnosis or visualization. The presence of a "forceps channel" for "inserting surgical instruments" further supports its use in therapeutic procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product is intended for "observation, diagnosis, and endoscopic treatment" of the lower digestive tract.
No
The device description clearly outlines numerous hardware components including a flexible tube, bending mechanism, lenses, channels for instruments, light guides, a CMOS image sensor, and a control portion with mechanical parts. The device system also includes a video processor and external monitor. Even though software testing (IEC 62304) is mentioned, the core functionality and physical embodiment of the device are undeniably hardware-based, not software-only.
No
The device is an endoscope used for visualization, diagnosis, and treatment of the lower digestive tract. It processes images of internal bodily structures, not in vitro diagnostic information, and its function relates to direct observation and intervention, not the examination of specimens derived from the human body for diagnostic purposes.
N/A
Intended Use / Indications for Use
This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Product codes
FDF
Device Description
The insertion portion of the device has a mechanism (hereinafter "the bending portion") which bends the tip from right to left and up and down, and a flexible tube (hereinafter "the flexible portion") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument.
The insertion portion of the endoscopes comes into contact with the mucosal membrane.
The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, Objective lens, and Light guide.
The bending portion is controlled by knobs on the control portion/operation section to angulate the distal end to certain angles.
The Flexible portion refers to the long insertion area between the Bending portion and the Control portion (a part of Non-insertion portion). This portion contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image and display the image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.
The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connector connects the endoscopes to the light source and video processor, respectively.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Electrical safety of the subject device was evaluated using following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2020, IEC60601-1-6:2020 and IEC 60601-2-18:2009.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2021. Biocompatibility testing was conducted in accordance with the FDA guidance, Use of International Standards ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16,2016.
Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2015, ISO 8600-3:2019, and ISO 8600-4:2014.
Software specific testing was conducted using the following consensus standards: IEC 62304:2015. The software validation activities were performed in accordance with the FDA Guidance, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17,2015.
The subject device met performance specifications in the following additional testing:
- Field of view
- Diameter of forceps channel
- Uneven illumination
- Bending capability
- Viewing direction
- Color reproducibility
- Rate of suction
- Resolution
- Air volume
- Working length
- LG output
- Water volume
Bench testing data regarding "Optical performance" demonstrated that the subject devices are substantially equivalent in performance to the predicate devices.
The subject devices FUJIFILM Endoscope Model EC-860P/M, EC-860P/L and EC-860S/L are substantially equivalent to the predicate devices based on the same intended use, indications for use, similar technological characteristics and materials. The differences in technological characteristics and materials between the subject and predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject devices are substantially equivalent in performance to the predicate devices. The difference in materials between subject and predicate devices has been validated through biocompatibility testing. Thus, the subject devices FUJIFILM Endoscope Model EC-860P/M, EC-860P/L and EC-860S/L are substantially equivalent to the predicate device, FUJIFILM Endoscope Model EC-760R-V/L(K172916).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
FDA 510(k) Clearance Letter - FUJIFILM Endoscope Models
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 23, 2025
Fujifilm Corporation
℅ Chaitrali Kulkarni
Sr. Regulatory Affairs Specialist
FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Suite 300
Lexington, Massachusetts 02421
Re: K243261
Trade/Device Name: FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FDF
Dated: April 25, 2025
Received: April 25, 2025
Dear Chaitrali Kulkarni:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Page 2
K243261 - Chaitrali Kulkarni Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K243261 - Chaitrali Kulkarni Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D.
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
510(k) Number (if known): K243261
Device Name: FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L
Indications for Use (Describe)
This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
K243261 Page 1 of 3
510(k) Summary
510(k)#: K243261
Prepared on: 2025-05-17
Contact Details
21 CFR 807.92(a)(1)
| Field | Information |
|---|---|
| Applicant Name | Fujifilm Corporation |
| Applicant Address | 798 MIYANODAI KAISEI-MACHI ASHIGARAKAMI-GUN KANAGAWA 258-8538 Japan |
| Applicant Contact Telephone | 704-517-4886 |
| Applicant Contact | Ms. Chaitrali Kulkarni |
| Applicant Contact Email | hcusregulatoryaffairs@fujifilm.com |
| Correspondent Name | FUJIFILM Healthcare Americas Corporation |
| Correspondent Address | 81 Hartwell Ave Suite 300 Lexington MA 02421 United States |
| Correspondent Contact Telephone | 704-517-4886 |
| Correspondent Contact | Ms. Chaitrali Kulkarni |
| Correspondent Contact Email | hcusregulatoryaffairs@fujifilm.com |
Device Name
21 CFR 807.92(a)(2)
| Field | Information |
|---|---|
| Device Trade Name | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L |
| Common Name | Endoscope and accessories |
| Classification Name | Colonoscope And Accessories, Flexible/Rigid |
| Regulation Number | 876.1500 |
| Product Code(s) | FDF |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K172916 | FUJIFILM Endoscope Model EC-760R-V/L | FDF |
| K190649 | FUJIFILM Endoscope Model EC-760S-V/L | FDF |
| K183572 | FUJIFILM Endoscope Models EC-760P-V/L | FDF |
| K222584 | EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLQ | FET |
Device Description Summary
21 CFR 807.92(a)(4)
A. Intended Use/indications for Use
Page 6
This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
B. Technological characteristics
The insertion portion of the device has a mechanism (hereinafter "the bending portion") which bends the tip from right to left and up and down, and a flexible tube (hereinafter "the flexible portion") consists of the bending portion and operating portion with a knob which controls the bending portion. The forceps channel which runs through the operating portion to the tip is arranged inside the insertion portion for inserting the surgical instrument.
The insertion portion of the endoscopes comes into contact with the mucosal membrane.
The tip of the insertion portion is called the "Distal end" which contains the Imaging section, Distal cap, Objective lens, Air/water nozzle, Water jet nozzle, Instrument channel outlet, Objective lens, and Light guide.
The bending portion is controlled by knobs on the control portion/operation section to angulate the distal end to certain angles.
The Flexible portion refers to the long insertion area between the Bending portion and the Control portion (a part of Non-insertion portion). This portion contains light guides (glass fiber bundles), air/water channels, a forceps/suction channel, a CMOS image sensor, and cabling. The glass fiber bundles allow light to travel through the endoscope to illuminate the body cavity, thereby providing enough light to the CMOS image sensor to capture an image and display the image on a monitor. The forceps channel is used to introduce biopsy forceps and other endoscopic accessories, as well as providing suction.
The control portion/operating section provides a grip to grasp the endoscopes and contains mechanical parts to operate the endoscopes. This section includes a Forceps inlet, which allows endoscope accessories to be introduced. The Scope connector connects the endoscopes to the light source and video processor, respectively.
C. Principles of Operation
The Endoscope Model EC-860P/M, EC-860P/L, and EC-860S/L function on the same principles of operation as the predicate device. EC-860P/M, EC-860P/L, and EC-860S/L are endoscopes for observation, diagnosis, and treatment of the lower digestive tract. After connecting to the light source, the devices guide the light through the fiber bundles situated inside the insertion portion of the device. The light that emits from the distal end of the insertion portion reflects from the target region and forms an image on the CMOS image sensor through a group of object lenses placed at the distal end of the devices. An electric signal from the image sensor is transmitted to the video processor connected to the device. The video processor converts the electric signal into a video signal and displays an image on a monitor.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
This product is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indication for use for the proposed device and the predicate devices are same.
Technological Comparison
21 CFR 807.92(a)(6)
Proposed device models come with optical characteristics compared to predicate devices. Although the differences in the optical characteristics have been tested through Bench testing and no new concern for safety or efficacy was seen.
a) EC-860P/M
The difference in the F# and resolution of the objective lens in EC-860P/M compared to the predicate device does not affect the safety or efficacy of the subject device because of bench testing data demonstrated that the proposed devices are substantially equivalent in performance to the predicate devices.
Also proposed device model has differences in the distal end diameter and total length compared to the predicate device does not affect the safety or efficacy of the subject device because this value is between predicate and reference devices.
The proposed device models have differences in materials in comparison to the predicate devices. The differences in the materials have been tested through biocompatibility testing and no new concern for safety or efficacy was seen.
b) EC-860P/L
The difference in the F# and resolution of the objective lens in EC-860P/L compared to the predicate device does not affect the safety or efficacy of the subject device because of bench testing data demonstrated that the proposed devices are substantially equivalent in performance to the predicate devices.
Also proposed device model has differences in the distal end diameter compared to the predicate device does not affect the safety or
K243261 Page 2 of 3
Page 7
efficacy of the subject device because this value is same as reference device.
The proposed device models have differences in materials in comparison to the predicate devices. The differences in the materials have been tested through biocompatibility testing and no new concern for safety or efficacy was seen.
c) EC-860S/L
The difference in the F# and resolution of the objective lens in EC-860S/L compared to the predicate device does not affect the safety or efficacy of the subject device because of bench testing data demonstrated that the proposed devices are substantially equivalent in performance to the predicate devices.
Also proposed device model has differences in the distal end diameter, flexible portion diameter and maximum diameter compared to the predicate device does not affect the safety or efficacy of the subject device because this value is the same as reference device
The proposed device models have differences in materials in comparison to the predicate devices. The differences in the materials have been tested through biocompatibility testing and no new concern for safety or efficacy was seen.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Electrical safety of the subject device was evaluated using following standards: ANSI/AAMI ES 60601-1:2012, IEC 60601-1-2:2020, IEC60601-1-6:2020 and IEC 60601-2-18:2009.
Biocompatibility of the subject device was evaluated using the following consensus standards: ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2021. Biocompatibility testing was conducted in accordance with the FDA guidance, Use of International Standards ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", issued June 16,2016.
Endoscope specific testing was conducted using the following consensus standards: ISO 8600-1:2015, ISO 8600-3:2019, and ISO 8600-4:2014.
Software specific testing was conducted using the following consensus standards: IEC 62304:2015. The software validation activities were performed in accordance with the FDA Guidance,Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005.
Validation of the cleaning, disinfection, and sterilization instructions was performed in accordance with FDA's guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," published March 17,2015.
The subject device met performance specifications in the following additional testing:
- Field of view
- Diameter of forceps channel
- Uneven illumination
- Bending capability
- Viewing direction
- Color reproducibility
- Rate of suction
- Resolution
- Air volume
- Working length
- LG output
- Water volume
Bench testing data regarding "Optical performance" demonstrated that the subject devices are substantially equivalent in performance to the predicate devices.
The subject devices FUJIFILM Endoscope Model EC-860P/M, EC-860P/L and EC-860S/L are substantially equivalent to the predicate devices based on the same intended use, indications for use, similar technological characteristics and materials. The differences in technological characteristics and materials between the subject and predicate devices raise no new issues of safety or effectiveness. Bench testing data demonstrated that the subject devices are substantially equivalent in performance to the predicate devices. The difference in materials between subject and predicate devices has been validated through biocompatibility testing. Thus, the subject devices FUJIFILM Endoscope Model EC-860P/M, EC-860P/L and EC-860S/L are substantially equivalent to the predicate device, FUJIFILM Endoscope Model EC-760R-V/L(K172916).
K243261 Page 3 of 3